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Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 012097
Company: DELCOR ASSET CORP

Products on NDA 012097

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
KENALOG IN ORABASE	TRIAMCINOLONE ACETONIDE	0.1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	PASTE;DENTAL	Discontinued	None	Yes	No

Approval Date(s) and History, Letters, Labels, Reviews for NDA 012097

Original Approvals or Tentative Approvals

Action Date	Submission	Action Type	Submission Classification	Review Priority; Orphan Status	Letters, Reviews, Labels, Patient Package Insert	Notes	Url
03/04/1960	ORIG-1	Approval	Type 3 - New Dosage Form	STANDARD		Label is not available on this site.

Supplements

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
05/22/1996	SUPPL-27	Manufacturing (CMC)-Control		Label is not available on this site.
11/19/1993	SUPPL-26	Manufacturing (CMC)-Packaging		Label is not available on this site.
06/13/1990	SUPPL-25	Manufacturing (CMC)		Label is not available on this site.
07/11/1988	SUPPL-24	Manufacturing (CMC)-Control		Label is not available on this site.
07/11/1988	SUPPL-23	Manufacturing (CMC)-Expiration Date		Label is not available on this site.
04/10/1987	SUPPL-21	Manufacturing (CMC)		Label is not available on this site.
11/30/1987	SUPPL-20	Manufacturing (CMC)		Label is not available on this site.
11/19/1986	SUPPL-19	Manufacturing (CMC)-Packaging		Label is not available on this site.
01/23/1986	SUPPL-18	Manufacturing (CMC)-Formulation		Label is not available on this site.
08/11/1983	SUPPL-17	Manufacturing (CMC)-Control		Label is not available on this site.
09/03/2002	SUPPL-16	Labeling	Label (PDF) Letter (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12097s16lbl.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2002/12907slr016LTR.pdf
06/16/1982	SUPPL-15	Manufacturing (CMC)-Control		Label is not available on this site.
08/21/1979	SUPPL-14	Manufacturing (CMC)-Control		Label is not available on this site.
07/17/1979	SUPPL-12	Manufacturing (CMC)		Label is not available on this site.
02/22/1978	SUPPL-9	Labeling		Label is not available on this site.
05/09/1977	SUPPL-8	Manufacturing (CMC)-Control		Label is not available on this site.
05/09/1977	SUPPL-7	Manufacturing (CMC)		Label is not available on this site.
02/08/1977	SUPPL-6	Labeling		Label is not available on this site.

Labels for NDA 012097

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
09/03/2002	SUPPL-16	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2002/12097s16lbl.pdf

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